I prepared for orals expecting a lot of questions. There were not many questions asked by Judge Norris or Judge Martin but quite a few by Judge Cook. Judge Norris and Martin are a couple of salty old dogs and seem a bit more lighthearted then many of their stiffer brethren.

I had 15 minutes, 5 of which I saved for rebuttal. I presented the issue and spoke about how this case was different then most FOIA cases in that we know that there were, and maybe still are, requested documents on the computer of a single individual at the FDA.

We know this by virtue of Richard Pazdur’s admittance that he had the documents on his computer but he deleted them. So in this case the CDER division of the FDA knows where to look. Continue Reading Care To Live Attorney Kerry M. Donahue Argues for Pazdur’s Deleted Documents »

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Care To Live is very concerned that too many men are again unable to access Provenge. The FDA continues to take its own sweet time inspecting Dendreon’s clean rooms in order that Dendreon be able to provide Provenge to more men now. The FDA fails to recognize the importance of rearranging its priorities, along with the need for taking things out of order sometimes.

In cases such as Provenge, whereby we have an unmet demand for a treatment for late stage cancer where there are no viable alternatives, the old “first in first out”, is not reasonable nor acceptable. Humanity compels this bureaucracy to look at the bigger picture, men’s lives, and to act non-bureaucratically.

Care To Live Inquired of CBER on August 26, 2010

XXXXXXXX

Please feel free to correct us if we are wrong but we understand that Dendreon’s New Jersey Plant is waiting on FDA approval before it can begin using the additional 75% plant capacity.

We understand that you are an extremely busy agency. However, it seems that there are some things that should be given at least some priority over others.

In this case Dendreon is way short of being able to satisfy the demand/need for Provenge. That combined with the fact that Provenge is for a late stage patient population makes timely certification of this plant all the more important.

We would request that CBER make all possible effort to timely certify the plant so as to enable more prostate cancer patients to benefit from this new treatment as soon as possible.

Thank you for the consideration.

Care To Live

________________________________________________

Response on September 1, 2010

Thank you for your recent inquiry to the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) regarding Provenge. CBER, one of seven centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products.

While we can not discuss specific details with you regarding the Dendreon plant, we appreciate your concerns regarding the availability of Provenge and take them very seriously.  The Agency recognizes the importance of new cellular therapies like Provenge, for serious diseases for which current treatment is unsatisfactory. We will continue to work closely with the manufacturer in its efforts to make Provenge available to the public.
Sincerely,
H.A.
Consumer Safety Officer
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
US Food and Drug Administration

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
__________________________________________

On October 15, 2010

XXXXXXX

The FDA has its new Fast TRACK program but there is no info there about sipuleucel-T (Provenge). Isn’t this supposed to show where the FDA is with regards to inspections?

We can’t figure out why inspection of the additional 75% of capacity of the NJ plant can’t be timely completed. This is a treatment for which demand far exceeds supply and it is for late stage prostate cancer patients.

The FDA’s Fast TRACK program is supposed to provide additional accountability and transparency on the process. Everyone should be entitled to know where the process stands at the FDA regarding this extremely important inspection. Importantly, can’t the process be given some priority considering the circumstances??

Care To Live

______________________

On October 19, 2010

Thank you for your recent inquiry to the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) regarding Provenge. CBER, one of seven centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products.

While we can not discuss specific details with you regarding the Dendreon plant, we appreciate your concerns regarding the availability of Provenge and take them very seriously.  The Agency recognizes the importance of new cellular therapies like Provenge, for serious diseases for which current treatment is unsatisfactory. We will continue to work closely with the manufacturer in its efforts to make Provenge available to the public.

If you have further questions regarding the availability of Provenge, you may contact the manufacturer, Dendreon Corp., directly at www.dendreon.com or 877-336-3736 regarding their product.

We hope this information is helpful.

Sincerely,
H.A.
Consumer Safety Officer
Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
US Food and Drug Administration

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The real story—the tragedy in this case, and the one yet to be told by the so-called “Mainstream Media”—is the story of the needless three-year delay in availability of Dendreon’s Provenge for our sons, fathers, and grandfathers.

The Dendreon Investor Village (IV) message board at www.investorvillage.com(link) is where a group of the most well-informed people in the world on all-things-Dendreon, exchange information. Many have posted there non-stop since early in the decade. One daily post entitled “Daily Death Count”, documents the number of men who have died of prostate cancer since “Black Wednesday” (link to Mark Thornton op ed), May 8, 2007, the date the FDA went against the recommendation of its own Advisory Committee and refused to approve Provenge. As of this past Thursday, the date Provenge received final approval, the death count stood at 90,055. Every one of these 90,055 men were deeply loved and now dearly missed by their families and friends.

It’s difficult to ignore the fact that the March 29, 2007 Provenge Advisory Committee voted unanimously (17-0) that the drug is SAFE, or the fact that the same Committee voted minutes later, (13-4) that the drug “demonstrated substantial evidence of efficacy,” the federally mandated standard in such reviews. But the FDA did. The FDA also ignored the fact that the treatment was being submitted to help men with end stage prostate cancer, the stage for which there is no viable treatment option. Provenge would have been their last resort. Continue Reading The Real Provenge Story »

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March 11, 2010

Dr. Sharfstein,

Can you please check with CBER and see why it is taking them so long to make a final decision on Dendreon’s Provenge.

The pending BLA is an amended BLA that was first submitted to the FDA in 2006. Following a March 2007 AC, in which the FDA hand picked experts overwhelmingly voted for approval, CBER decided to require additional proof of efficacy. That additional proof, as set forth in the SPA, was in fact obtained by Dendreon with results being announced in April 2009 (interim data was also positive and the IDMC also recommended approval in October 2008).

Now CBER has had all the new clinical data from the IMPACT trial as of July 2009 and all the CMC data since October 2009. Despite promises from CBER to the advocacy group CareToLive and others that they would review this treatment, intended for late stage prostate cancer, expeditiously, the treatment inexplicably remains unavailable.

This review is hardly being done expeditiously. FDA has now delayed this treatment from reaching patients for 3 years.

Please inquire/help.

Kerry M. Donahue, Esq.

Counsel for CareToLive

Dublin, Ohio

CTL Petition for reconsideration of May 2007 decision to issue CR filed in July 2007.

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FDA’s CBER Gone Fishing While Men Gone Wishing

Read it here http://www.nowpublic.com/health/fdas-cber-gone-fishing-while-men-gone-wishing 

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FDA’S Cber Sipping New Year’s Champagne Burst Patient’s Bubbles

http://my.nowpublic.com/health/fdas-cber-sipping-new-years-champagne-burst-patients-bubbles

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Hold the deck.

It’s certainly okay to have the opinion that the FDA made a reasonable choice at the time it denied approval to Provenge in 2007. It’s not the right opinion, but it is a defendable one. It is not all right, based on what we now know, to say they made the right decision.

On the other hand:

That the Provenge BLA was not afforded proper due process is an absolute. Because it clearly was not afforded proper due process nobody can say with any certainty that the FDA made a reasonable decision. Once the process is corrupted it’s all guesswork from there. Nobody knows for sure the extent of influences and back room shenanigans that occurred to assure that Provenge was not fairly evaluated. When CareToLive through litigation and FOIA’s tried to get information they were stymied by the FDA who went to great lengths to avoid any transparency on the issue.

There are aces scattered all over the floor at the FDA and a couple sticking out of a few sleeves so how can the game have been fairly played? Is it too much to ask for a fair game? The denial of a fair PROCESS is the one truth that the FDA could have, should have, admitted.

If that process occurred in a court room there would, at a minimum, have been declared a mistrial, when the evidence of such became known (which was made known to the FDA by petition, litigation and of course lots of letters).

That they did not make a reasonable and common sense decision based on the class of patients for which Provenge was seeking approval, or conduct a proper risk/benefit analysis with a focus on the fact that the treatment was destined for late stage patients is clear.

The FDA said two things that support this; One was that the minority voices on the AC panel were taken into consideration as a factor in the decision making process, and Two is that Richard Pazdur of CDER influenced that process. Top that off with an FDA commissioner who just happens to be a very good friend of Milken……

I don’t want the point to be lost that it is the position of CareToLive that there is no way anyone can say a reasonable decision was made, because the process was completely corrupted. CareToLive has sought accountability and transparency to determine in what ways the process fell short. If the FDA would show us the process then we might be persuaded otherwise. Until then and even because of the cover up itself, it has to be evaluated based on what we know.

The cover up and the lack of transparency is indicative that the FDA made a choice that transparency would make matters worse in this case. Otherwise, why fight so hard to keep the process from the public eye.

What other influences entered into the picture. Political pressure? Milken pressure? Financial pressure? Inside power struggles? Some or all of the above?

The deck was stacked. The dice were loaded. Everybody knows!

With all that you now know about Milken and the depths of his depravity, does it not trouble you that he had considerable control and influence over at least Scher, Martin and von Eschenbach if not others? Continue Reading American Hold ‘Em »

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MOTION FOR LEAVE TO CONDUCT/COMPLETE DISCOVERY UNDER CIVIL RULE 56(f)
AND PARTIAL MEMORANDUM CONTRA TO DEFENDANT FDA’S MOTION FOR SUMMARY JUDGMENT

Now Comes Plaintiff, CareToLive, on behalf of its members and all suffering late stage prostate cancer patients and their families who have now been denied a proven safe and effective treatment for over two years and request leave from this Court to conduct a limited amount of discovery so as to more fully respond to the Motion for Summary Judgment filed by Defendant, as further set forth in the attached memorandum.

Link to Motion >> ctlfoiaresponse6-06-09c.pdf

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While Michael Milken and the Prostate Cancer Foundation are whooping it up at the ballgame, some men are sneaking off to have their testicles removed in hopes that it will stop their PSA from rising, and their lives from ending prematurely from late stage prostate cancer. 1 in 6 men will be diagnosed with prostate cancer in their lifetimes. Over 30,000 American men will die from prostate cancer this year. Only 1 very toxic drug has been approved for late stage pc in over 42 years.

Along came Dendreon’s Provenge, an Immunotherapy voted overwhelmingly safe and effective by the FDA’s panel of experts convened to review Provenge. Was there foul play afoot when the FDA decided to delay approval. Perhaps if our men put some extra pine tar on their bats, we could get some coverage of this story. You would think that the deaths of 15,000 men since the delay would be enough.

Note the Picture on the bottom — David Solit, Tommy Lasorda, Dr. Howard Soule, Dr. Howard Scher and Mike Milken join together in support of the PCF’s Home Run Challenge at the New York Mets vs. Anaheim Angels game on June 10th, 2005 (click link)

Why hasn’t Michael Milken and his Prostate Cancer Foundation stepped up to the plate and publicly voiced his disappointment and disapproval of the decision by the FDA to delay Provenge? Is Milken financially conflicted? The whole thing is permeating a stench in the world of financially conflicted advocacy groups. Continue Reading Michael Milken and the Prostate Cancer Foundation’s Foul Balls »

Popularity: 28%

Download the Memorandum - Click here

CareToLive Attorney Kerry Donahue files on behalf of the men with terminal prostate cancer who are running out of hope and time as thet desperately seek Provenge. We need everybody’s help in calling attention to this grave situation. Please Leave your comments and digg it. TIA

P.S. Two fleets of buses are rolling around DC and Rockville with our “Get on the Bus Gus” Provenge Confidential ad campaign.

Popularity: 22%